Business
BioCardia Announces Positive DSMB Recommendation to Continue Phase 3 Pivotal CardiAMP Heart Failure Study as Planned
SAN CARLOS, Calif., Sept. 16, 2019 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular
About this update from Biocardia, Inc.
[{"type":"text","content":"SAN CARLOS, Calif., Sept. 16, 2019 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP Heart Failure Trial, which included safety follow-up results on 35 patients and all additional data available on the 50 patients randomized in the trial as of August 31, 2019. The DSMB indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned. \n The ongoing multi-center, double-blinded, randomized (3:2), sham-controlled pivotal CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40 centers nationwide. The trial’s primary efficacy endpoint is Six Minute Walk distance at 12 months’ post-treatment, a measure of a patient’s exercise capacity, and incorporates the impact of MACE and other clinically meaningful events. Secondary efficacy endpoints include quality of life as measured by the Minnesota Heart Failure Quality of Life self-assessment, and superiority relative to MACE and survival. The national co-principal investigators are Amish Raval, MD, of the University of Wisconsin and Carl Pepine, MD, of the University of Florida, Gainesville. “We are pleased that the comprehensive data achieved to date has led to a positive recommendation from the DSMB to continue the CardiAMP Heart Failure Trial. We are focused on accelerating enrollment with our world class clinical partners and delivering the evidence necessary to bring CardiAMP Cell Therapy to U.S. patients,” said Eric Duckers, MD, PhD, Chief Medical Officer of BioCardia. Patients interested in learning about the study can visit www.cardiamp.com or www.clinicaltrials.gov for more information. The next prespecified DSMB review is anticipated in the first quarter 2020. About the CardiAMP Therapy ProgramCardiAMP cell therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally-invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. The CardiAMP Heart Failure Trial is the first multicenter clinical trial of a stem cell therapy to prospectively screen for stem cell therapeutic potency in order to ...